ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM

K061310 · Ziehm Imaging, Inc. · JAK · Jul 7, 2006 · Radiology

Device Facts

• Record ID: K061310
• Device Name: ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM
• Applicant: Ziehm Imaging, Inc.
• Product Code: JAK · Radiology
• Decision Date: Jul 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The ZIEHM VARIO and ZIEHM VARIO 3-D C-arms provide fluoroscopic and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. It is intended to be used whenever the Clinician benefits from Iso-centric positioning and/or intraoperatively generated 3D imaging of high contrast objects (bones and joints), complex anatomical structures such as cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities. The design includes features intended for performing vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures. At the discretion of a physician the device may be used for other imaging applications. Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.

Device Story

Mobile C-arm x-ray system; provides fluoroscopic, spot film, and intraoperative 3D imaging. Inputs: x-ray radiation; outputs: 2D/3D digital images displayed on dual LCD monitors. Components: mobile stand with high-frequency generator, x-ray tube, image intensifier, laser localizers; monitor cart with digital image memory, processing, and touch interface. Used in hospitals, clinics, and ORs by physicians, surgeons, cardiologists, radiologists, and technologists. Supports iso-centric positioning for 3D reconstruction of high-contrast anatomical structures. Integrates with Computer Aided Surgery (CAS) systems via interface; supports DICOM 3 and external media storage. Benefits: enables real-time intraoperative visualization of complex anatomy and fractures, facilitating surgical guidance and diagnostic accuracy.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and compliance with recognized international safety and performance standards for diagnostic x-ray systems and medical electrical equipment.

Technological Characteristics

Mobile C-arm; high-frequency x-ray generator; image intensifier; dual flat-panel LCD monitors. Connectivity: DICOM 3, RS-170/CCIR video, CAS interface. Standards: 21 CFR 1020.30/31, UL 60601-1, IEC 60601-1 series (safety, EMC, radiation protection), IEC 60825-1 (laser). Features integrated laser light localizers and iso-centric positioning mechanism.

Indications for Use

Indicated for patients requiring fluoroscopic and spot film imaging during diagnostic, interventional, and surgical procedures, specifically for high-contrast objects (bones/joints), complex spinal anatomy (cervical, thoracic, lumbar), and extremity fractures. Used in vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, and emergency procedures.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• SIEMENS Medical Systems AG ISO-C 3D Mobile Surgical C-arm System (K003266)
• SIEMENS Medical Solutions USA, ISO-C 3D Mobile C-arm System (K032280)

Submission Summary (Full Text)

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#### 510(k) Summarv

# Kob 1310

In accordance with the requirements of 21 CFR \$807.92 the following summary of 510(k) safety and effectiveness information for the Ziehm Vario / 3D Family is being submitted.

#### Date:

April 29, 2006

#### Name of Submitter:

JUL - 7 2006

Ziehm Imaging, Inc. 4181 Latham Street Riverside, CA 92501 [phone]

#### Corresponding Official:

Richard Westrich. V.P. Product Development, Regulatory Affairs

#### Device Proprietary Name:

Ziehm Vario 3D Mobile Imaging System

#### Classification Name:

System, X-ray, Fluoroscopic, Image-Intensified or System, X-ray, Mobile

#### Common/Usual Names:

Digital Mobile C-Arm, Fluoroscopic imaging System, Digital Mobile Imaging System

#### Substantial Equivalence:

The ZIEHM VARIO 3D is substantially equivalent to the following devices that are currently marketed:

- SIEMENS Medical Systems AG ISO-C 3D Mobile Surgical C-arm System 510(k) K003266 ー
- SIEMENS Medical Solutions USA, ISO-C 3D Mobile C-arm System 510(k) K032280 -

These devices are mobile C-arm x-ray systems intended for fluoroscopic and 3d imaging. The systems include high-voltage x-ray generator and control, x-ray tube, image intensifier, and monitor cart/workstation, with video image displays, 2D and 3D digital image processing and innage storage capability, Computer Aided Surgery (CAS) interface, as well as conventional sports may storage

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#### Device Description:

Indications for Use

Kó6 13/0

The ZIEHM VARIO and ZIEHM VARIO 3-D C-arms provide fluoroscopic and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. It is intended to be used whenever the Clinician benefits from Iso-centric positioning and/or intraoperatively generated 3D imaging of high contrast objects (bones and joints), complex anatomical structures such as cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities. The design includes features intended for performing vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures. At the discretion of a physician the device may be used for other imaging applications.

Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.

#### User Characteristics:

The device is intended to be used by health care professionals such as physicians, surgeons, cardiologists, radiologists and technologists in hospitals, out-patient clinics and other clinical environments. It is expected that the device will be used on a nearly daily basis. Ziehm Imaging applications specialists and/or qualified site personnel provide on site operator training in the proper use of the device.

#### Device Description

The ZIEHM VARIO 3D has two main units; Mobile Stand and Monitor Cart workstation. The Mobile Stand C-arm consists of a high frequency generator, x-ray tube assembly, image intensifier, and user. touch control interface, C-Profile supporting the generator and image intensifier and Integrated Laser light localizers in the image receptor. The Mobile Stand C-profile provides fixed distance mounting of the generator and image receptor allowing the user rotational and linear movements for positioning the c-arm at various angles and distances for visualization of patient's anatomical structures in addition the device has variable ISO Centric operation, and integrated Iso-centric operations for performing 3D imaging.

The monitor cart workstation supports dual flat panel LCD display monitors, digital image memory device, imaging capture, image processing, and touch control user interface. External Video connection is provided with RS-170 video timing for domestic market, CCIR for International markets. The ZIEHM VARIO 3D also provides optional peripheral connections for such devices as video printers, DICOM 3, CAS connection for image guided surgery and external media storage devices.

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## 1661310

The ZIEHM VARIO 3D series mobile x-ray systems were designed to comply with applicable portions of the following standards and regulations for product safety requirements:

- Federal Performance Standard for Diagnostic X-ray Systems 21 CFR 1020.30, 21 CFR -1020.31 and 21 CFR 1020.30
- --UL 60601-1 Medical Electrical Equipment
- IEC 6060'1-1, Medical Electrical Equipment, General Requirements for l Safety
- IEC 60601-1-2, Medical Electrical Equipment, General Requirements for Safety, m Electromagnetic Compatibility
- IEC 60601-1-3, Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray -Equipment
- IEC 60601-1-4, General requirements for safety, Programmable electrical medical --systems.
- IEC 60601-2-7, Medical Electrical Equipment, Safety of HV/X-ray -Generators
- IEC 60601-2-28, Medical Electronic, Particular Requirements for Safety of ﺳﮯ X-ray Source Assemblies, and X-ray Tube Assemblies.
- IEC 60601-2-32, Medical Electrical Equipment, Safety of Associated X-ray --Equipment
- -IEC 60825-1, Safety of Laser Products, Equipment Safety , Requirements, and User Guide
- 93/42/EEC Annex 1 Essential Requirements of the Medical — Devices Directive
- । DIN ISO 14971

#### Conclusion:

Standards:

The ZIEHM VARIO 3D does not raise new questions of safety or effectiveness and is substantially equivalent to the current legally marketed devices SIEMENS ISO-C 3D K003266, and SIEMENS ISO-C 3D K032280.

End of 510(k) Summary

Richard Westrich

Vice President Product Development and Regulatory Affairs Ziehm Imaging, Inc. Riverside, CA 92501

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL - 7 2006

Mr. Richard Westrich Vice President of Product Development and Regulatory Affairs Ziehm Imaging, Inc. 4181 Latham Street RIVERSIDE CA 92501

Re: K061310

Trade/Device Name: Ziehm Vario 3D Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: JAA and IZL Dated: April 29, 2006 Received: May 10, 2006

Dear Mr. Westrich:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. hogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications For Use Statement

Applicant:

Ziehm Imaging, Inc.

510(k) Number (if known): K 00 13 10

Device Name: ZIEHM VARIO 3D

Indications for Use:

The ZIEHM VARIO and ZIEHM VARIO 3-D C-arms provide fluoroscopic and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. It is intended to be used whenever the Clinician benefits from Iso-centric positioning and/or intraoperatively generated 3D imaging of high contrast objects (bones and joints), complex anatomical structures such as cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities. The design includes features intended for performing vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures. At the discretion of a physician the device may be used for other imaging applications.

Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Snowdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number